Halaven® is one of the most complex totally synthetic drugs ever approved. This presentation
will provide examples of how the application of a rational scientific approach helped create the innovative
solutions that effectively meet the specialized development needs of this unique product.The assessment of
risk associated with new drug development often dominates discussions of pharmaceutical commercialization.
Effective risk management through rational analysis can generate innovative solutions, novel opportunities,
competitive advantage, while driving organizational performance.

This session will examine the current environment of BioManufacturing and consider industry-wide pressures
and external events that led to our current state. We will highlight the components of manufacturing cost
that should not be reduced, given industry’s commitment to delivering quality products to patients, and
explore potential solutions for meeting cost constraints impacting each of our organizations.

This presentation will explore how the factory of the future for Pharmaceutical Manufacturing will look
and operate. We will examine enablers of the factory of the future, including technological breakthroughs. We
will also examine how the factory of the future will enhance efficiency, quality and compliance through
operational excellence and advanced automation and control. Will future factories be designed for shorter
life cycle? Large or small scale processing? What skills will be needed to operate these facilities? We will
examine these questions and many more.